24/01139 Instrument for extraction of DNA/RNA from viruses with consumables and service - FHI | Norsk Helsenett SF

Dato	Dokument
2024-08-28	Kunngjøring av konkurranse

The Department of Virology at the Norwegian Institute of Public Health shall procure an extraction instrument that enables extraction of DNA and RNA from viruses in different sample materials for further molecular analyses such as PCR and sequencing/NGS. The instrument is mainly intended for extraction of hepatitis virus, but other viruses may also be relevant. The extraction platform shall be particularly suitable for extraction of viruses (i.e. hepatitis A, B, C, D and E) from plasma and serum (in 2023 nucleic acid extraction was carried out by FHI of approx. 1,000 hepatitis virus samples; approx. 600 for RNA and 400 dna for further PCR analyses and sequencing/NGS, but the number will vary depending on the project and the number of samples submitted). Furthermore, the instrument should also be suitable for the extraction of virus DNA/RNA from sample materials such as urine, spit, faeces, LBC (liquid based cytology - cervix cervology samples), fresh tissue and formal in fixated tissue. Emphasis will be put on the instrument being flexible as regards sample volume, eluat volume and the number of samples that can be extracted simultaneously. The instrument shall be able to analyse a minimum of 24 samples at the same time, and the extraction process should be as automated as possible. It is not desirable to have a large instrument, both due to limited space in the laboratory and a limited number of samples, so weighting of space efficient equipment (i.e. "bench-top" instrument). Input sample volume (including dead volume) should be 500μl or less. The flexible input volume or different protocols, for example 200, 500 and 1000ul, are sufficient. The flexible electrical installation volume is desirable, ideally down to 50μl, or lower. Emphasis will also be put on traceability of samples and kits. We would like to have a bar code reader and/or an option for the import/export of sample ID to/from LIMS. The price per sample shall as far as possible be independent of the number of samples set up. Documentation is wanted from studies that show comparing hepatitis virus extraction outcomes against one of the most common extraction platforms, such as MagNApure96, easyMAG/eMAG or QIAamp kits, as well as suitability for NGS analyses. In addition FHI would like to carry out a comparative testing of all tenderers in the competition, so that tenderers who wish to participate in the competition must be able to fulfil the following criteria: Give FHI the possibility to send sample material to the supplier (or to the user laboratory in accordance with instructions from the tenderer) who further carry out extractions of up to 48 hepatitis virus samples (serum/plasma) and send the eluat back to FHIVIKTIG: Tests for testing will be available for tenderers at FHI from day two after the submission deadline. The tests (extraction of up to 48 hepatitis samples) shall be carried out during weeks 42-43 and FHI shall be delivered by 25.10.2024, 12:00. After this date FHI will carry out further tests of the eluats as well as virus exchange and suitability for the intended use. This result will be of great importance in the selection of the ectraction platform. A product procurement contract will be signed for the instrument and a framework agreement for consumables/reagents.

'Total' annual turnover: The tenderer ́s ("total") annual turnover for the number of financial years requested in the tender notice or in the procurement documents is as follows:

Average annual turnover: The tenderer ́s average annual turnover for the number of years requested in the notice or in the procurement documents is as follows:

"Specific annual turnover": Are the tenderer's ("specific") annual turnover within the area that the contract applies to and specified in the notice or in the procurement documents for the number of accounting years requested is as follows:

Average set-up: Is the tenderer's average annual turnover within the area requested by the contract and specified in the notice or in the procurement documents for the number of financial years requested:

The tenderer's establishment date: If the information about the turnover (combined or specific) is not available for the entire requested period, please state the date the company was established, or the tenderers started their business:

Financial key figures: For financial key figures stated in the notice or in the procurement documents, the tenderer declares that the actual value(s) of the requested key figures are as follows:

Liability insurance: The insured amount in the tenderer ́s liability insurance is the following:

Other economic and financial requirements: Regarding any other economic and financial requirements that have been stated in the notice or in the procurement documents, the tenderer declares that: Minimum qualification requirements Description of the requirement/documentation: Requirement: The tenderer shall have sufficient economic and financial capacity to be able to fulfil the contract. Documentation requirement: The requirement shall be documented by a credit rating based on the last known accounting figures. The rating shall be carried out by a credit rating company with licence to conduct this service. Creditworthiness with no requirement for collateral will be sufficient to meet the requirement.

Certificates issued by independent bodies for…

… quality assurance standards.: Can tenderers submit certificates issued by independent bodies that document that the tenderer fulfils the stated quality assurance standards, including universal design requirements? Minimum qualification requirements Description of requirements/documentation: Tenderers shall have established satisfactory systems for quality assurance of the services that shall be provided. Documentation requirement: Statement regarding the company's quality assurance system. If a tenderer is certified by a public certification body, it is sufficient to enclose a copy of an issued certificate. If a tenderer is not certified, the quality system must be documented, e.g. by enclosing a quality handbook that provides a description of the quality management system and how it is implemented in the organisation. The requirement must be met by both the tenderer and any cooperating companies.

… environmental management standards.: Is the tenderer able to submit certificates issued by independent bodies as documentation that the tenderer fulfils the stated environmental management systems or standards?

Registered in a trade register: Tenderers are registered in a professional register in the member state in which the tenderer is established. As described in annex XI of directive 2014/24/EU; suppliers from certain member states may have to fulfil other requirements in the mentioned annex.

Registered in a trade register or company register.: Tenderers are registered in a company register or a trade register in the member state in which the tenderer is established. As described in annex XI of directive 2014/24/EU; suppliers from certain member states may have to fulfil other requirements in the mentioned annex. Minimum qualification requirements Description of the requirement/documentation: Requirement: Tenderers shall be registered in a company register, professional register or a commerce register in the country where the tenderer is established. Documentation requirement: Norwegian companies: Company Registration Certificate. Foreign companies: Verification that the tenderer is registered in a company register, professional register or a commerce register in the country where the tenderer is established.

Only for public goods deliveries: Only for public goods deliveries: In the reference period, the tenderer has carried out the following important deliveries of the requested type, or the following important services of the requested type. The contracting authority can require up to three years experience and allow experience from the previous three years to be taken into consideration.

Technical personnel or technical units: Tenderers can use the following technical personnel or technical units , particularly those who are responsible for quality control: For technical personnel or technical units that do not directly belong to the tenderer ́s business, but if the capacity the tenderer will use, cf. part II, section C, separate ESPD forms shall be supplemented.

Technical facilities and quality assurance measures: The tenderer utilises the following technical facilities and quality assurance measures and the tenderer ́s survey and research facility is as follows:

Investigation and research facilities: The tenderer ́s survey and research facilitates are as follows:

Management and tracing of the supply chain: The tenderer will be able to use the following management of the supply chain and tracing systems for the execution of the contract:

Control Permission: For goods or services that are complicated, or that in exceptional cases shall be used for a particular purpose: Will the tenderer allow checks of the tenderer's production capacity or technical capacity and, where necessary, of the survey and research facilities that the tenderer has at its disposal and of quality control measures? The inspections shall be undertaken by the contracting authority or the contracting authority can leave it to a competent public body in the country where the tenderer is established.

Education and professional qualifications: The following education and professional qualifications are possessed by the tenderer and/or (depending on the requirements set in the notice or in the procurement documents) of the leading employees:

Environmental management measures: Tenderers can employ the following environmental management measures in connection with the execution of the contract:

Number of employees in the management: The tenderer ́s number of employees in the management during the last three years was as follows:

Average workforce: The tenderer's average annual workforce in the last three years has been as follows:

Tools, materials and technical equipment.: Tenderers can use the following tools, material and technical equipment to carry out the contract:

Portion of the contract to sub-suppliers.: The tenderer is considering to outsource the following part (as a percentage) of the contract to sub-suppliers. Note that if the tenderer has decided to outsource a part of the contract to sub-suppliers and will use the sub-suppliers ́ capacity to carry out this part, a special ESPD will be supplemented for such sub-suppliers, see part II, section C, above.

Procurement of goods: Requested samples, descriptions or photographs…

… that do not need to be accompanied by certificates that they are genuine.: Procurement of goods: The tenderer presents supplies that shall be delivered, requested samples, descriptions or photographs, which do not need to be accompanied by certificates that they are genuine.

… with certificates.: When procurement of goods: If requested, the tenderer further declares that they will deliver the requested certificates that they are genuine.

When procuring goods: Certificates issued by official bodies for quality control: Can tenderers submit the requested certificates issued by official bodies for quality control, and who can confirm that the goods, which are clearly identified by reference to technical specifications or standards, as determined in the notice or in the procurement documents, are in accordance with these?

Barnearbeid og andre former for menneskehandel

Bedrageri

Betaling av skatter

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Betaling av trygdeavgifter

Deltakelse i en kriminell organisasjon

Hvitvasking eller terrorfinansiering

Korrupsjon

Terrorhandlinger eller handlinger knyttet til terrorvirksomhet

Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies,…

… in the event a enforceable verdict has been convicted of corruption by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Corruption as defined in Article 3 of the Convention on Combating Corruption, Involving European Communities or European Union Member States (EUT C 195 of 25.6.1997, s. 1), and in Article 2, point 1, in the Council ́s framework decision 2003/568/RIA of 22 July 2003 on combating corruption in the private sector (EUT L 192 of 31.7.2003, p. 54). This rejection reason also includes corruption as defined in national law for the contracting authority or supplier.

… at the time a legally convicted verdict of participation in a criminal organisation by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Participation in a criminal organisation as defined in Article 2 of the Council ́s framework decision 2008/841/RIA of 24 October 2008 on control of organised crime (EUT L 300 of 11.11.2008, p. 42)

… in the event a legal verdict has been convicted of money laundering or financing terrorism by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Money laundering or financing terrorism As defined in Article 1 of the European Parliament and Council Directive 2005/60/EF of 26 October 2005 on preventive measures against the use of the financial system for money laundering and financing terrorism (EUT L 309 of 25.11.2005, p. 15).

… at the time a legally convicted of fraud has been convicted of fraud by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Fraud included in Article 1 of the Convention on protection of the Financial Interests of the European Communities (EFT C 316 of 27.11.1995, p. 48).

… in the event a legal verdict has been convicted of child labour and other forms of human trafficking by a verdict handed down no more than five years ago, or a rejection period determined directly in the judgement that still applies? Child labour and other forms of human trafficking as defined in Article 2 of the European Parliament and council directive 2011/36/EU of 5. 1 April 2011 on the prevention and control of human trafficking and the protection of its victims and for compensation of the Council ́s framework decision 2002/629/RIA (EUT L 101 of 15.4.2011, p. 1).

Have tenderers failed to fulfil all their social security obligations in the country where they are established and in their member state, if this is a different country than what he is established in?

Has the tenderer not fulfilled his tax and duty obligations in the country in which he is established, and in the contracting authority's member state, if this is a different country than what he is established in?

Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body, or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of acts of terrorism or criminal acts connected to terrorist activities by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Acts of terrorism or criminal acts relating to terrorist activity as defined in Article 1 and 3 of the Council ́s framework decision 2002/475/RIA of 13 June 2002 on combating terrorism (EFT L 164, af 22.6.2002, p. 3). This rejection reason also includes incitement to, participation or attempts to commit such actions as included in Article 4 in the mentioned framework decision.